Nilotinib is the compound 4-methyl-N[3-(4-methyl-1H-imidazol-1-yl-5-(trifluoromethyl)phenyl]-3-{{4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide and is of Formula (I):
Nilotinib is a protein tyrosine kinase inhibitor.
The preparation of Nilotinib and the use thereof, especially as an antitumor agent, are described in WO 2004/005281 (Novartis Pharma) which was published on 15 Jan. 2004. WO 2004/005281 (which corresponds to U.S. Pat. No. 7,169,791) describes the synthetic route depicted in Scheme 1 below.

The specific reagents and reaction conditions used in this process are described in WO 2004/005281. The present inventors have observed the following problems with the process described in WO 2004/005281:
1. In step-1
                (i) The yield of compound of formula (VII) is very low (25-30%) with low purity (90%).2. In step-2        (i). The yield of compound of formula (IX) is low (35%) making the process unviable.        (ii) The reaction time is very lengthy (65 hours), which could be problematic for commercial scale operations.        (iii) Use of diethyl ether is not adaptable on commercial scale production because it is highly flammable and very volatile.3. In step-4        (i) The yield of compound of formula (I) is very low (20-30%) thereby making the process uneconomical for commercial production.        (ii) Usage of the toxic and expensive propyl phosphonic anhydride as a reagent makes this process impractical for manufacturing scale operations.        There therefore exists a need for an improved process for manufacturing Nilotinib, which achieves high yields and purity, combined with overall process efficiency.        